Prescribing Information Archives

FDA Approves New Kyprolis Combination Regimen

Approvals, Blockbusters, Dexamethasone, Dosing, Expanded Approval, FDA, FDA/Regulatory, Once-Weekly Dosing, Prescribing Information, Relapse/Refractory Multiple Myeloma, Therapeutics, Triple Regimens, Twice-Weekly Dosing

The U.S. Food and Drug Administration approved the expansion of Amgen’s Kyprolis (carfilzomib) U.S. prescribing information to include the product’s use in combination with Darzalex (daratumumab) plus dexamethasone (DKd) in two dosing regimens – once weekly and twice weekly – for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy.

August 20, 2020/by PR Newswire

Novartis Receives FDA Approval For New Prescribing Information For Blockbuster PsA Treatment Cosentyx

Active Psoriatic Arthritis (PsA), Clinical Data, FDA/Regulatory, Interleukin-17A (IL-17A), Monoclonal Antibodies, Prescribing Information

FDA approved inclusion of new evidence that Cosentyx significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA).

June 19, 2018/by PR Newswire